Implications of the Ruling to Suspend FDA Approval of Mifepristone by a Federal Judge in Texas

By: Kalani Phillips, MPH, CPH

Mifepristone is a prescription drug approved by the FDA to be used for medication abortion. Medication abortions make up over fifty percent of all abortions in the United States (US) and research continually shows that unsupervised medication abortion is both safe and effective at terminating pregnancy during the first trimester. Despite the overwhelming scientific evidence highlighting the safety of mifepristone, a federal Judge in Texas has ruled to suspend the Federal Drug Administration’s (FDA) 23 year old approval of the drug in Alliance for Hippocratic Medicine v. FDA. This ruling will make it more difficult for people to get abortions, even in states where abortion is still legal. Moreover, this ruling calls into question the authority of the FDA, meaning that limiting access to mifepristone could have implications for accessing other prescription drugs in the US.

Mifepristone has been available in the US since 2000, but federal Judge Matthew J. Kacsmaryk of Texas declared the FDA’s approval was invalid and mifepristone should be taken off the market. The anti-abortion groups and doctors that filed the lawsuit claim that the FDA did not adequately follow safety procedures, and that the drug is likely unsafe because of that. However, the FDA disagrees with these statements, highlighting the years of established scientific evidence showing that mifepristone is safe and effective.

On the same day as the ruling by Judge Kacsmaryk, federal Judge Thomas Rice of Washington state issued an opposing ruling on a different case to not limit access to mifepristone. This could potentially void Judge Kacsmaryk’s ruling in some states, but the Supreme Court will have to make the final decision.

In reaction to these rulings, the Justice Department stated that it would ask the Supreme Court to block the rulings by a federal court of appeals. On April 12th, the Fifth Circuit Court of Appeals ruled that mifepristone would remain accessible while the lawsuit proceeds in the courts. However, they also ruled that in this time mifepristone will no longer be able to be sent through the mail or prescribed by healthcare providers that are not doctors. However, the Justice Department also disagrees with this ruling, stating that access to safe and effective reproductive care is essential.

As the fight for abortion continues, the Supreme Court will need to resolve the conflict and decide on the merit of each ruling. Until then, attorney Adam Unikowsky recently stated during an interview with NPR that the decision is “indefensible” and “not legally sound”. This is because the anti-abortion groups and doctors that filed the lawsuit cannot show they’re actually harmed by the FDA approval of mifepristone because these doctors and groups do not prescribe the drug to their patients. Their argument, however, is that while they do not prescribe the abortion pill themselves, they could treat patients who had taken it, which would potentially cause harm to their beliefs that are “emotionally taxing”, and impact their quality of life.

Additionally, Unikowsky stated that the statute of limitations has expired. The plaintiffs filed a petition challenging the FDA’s approval back in 2016, which was denied. They had six years (until March 2022) to file a lawsuit, but they waited until November 2022 to file, meaning the claim should have been time-barred. Still, it is unclear what the Supreme Court will ultimately decide. On April 14th, they did issue a temporary stay to maintain the status quo, ensuring that access to mifepristone will remain available as the final resolution of the case is pending.

After the overturning of Roe v. Wade last year, 13 states have already banned or seriously restricted clinically-supported abortion care. While there is a wide breadth of scientific evidence showing that mifepristone is safe and effective–even when used without clinical supervision–the ruling by Judge Kacsmaryk underscores a blatant disregard for research and a gross mistrust in evidence-based science, as well as the FDA. Moreover, this is the first time a judge has called into question the authority of the FDA. The implications of this ruling in determining access to medications throughout the US is worrisome for the future.

Sources:

Belluck, P. (2023a, April 7). Judge Invalidates F.D.A. Approval of the Abortion Pill Mifepristone. https://www.nytimes.com/2023/04/07/health/abortion-pills-ruling-texas.html?campaign_id=60&emc=edit_na_20230407&instance_id=0&nl=breaking-news&ref=headline&regi_id=178478248&segment_id=129890&user_id=c1a6095d08b347c7e4b6a1877382d7e0

Belluck, P. (2023b, April 13). Justice Department to Seek Emergency Supreme Court Action on Abortion Ruling. https://www.nytimes.com/2023/04/13/health/abortion-pill-ruling-appeal.html?campaign_id=60&emc=edit_na_20230413&instance_id=0&nl=breaking-news&ref=cta&regi_id=178478248&segment_id=130289&user_id=c1a6095d08b347c7e4b6a1877382d7e0

Belluck, P., & Liptak, A. (2023, April 12). Here’s What Happens Next in the Abortion Pill Case. https://www.nytimes.com/2023/04/12/us/politics/abortion-pill-ruling-explainer.html

Leonhardt, D. (2023, April 12). The Battle Over Abortion Drugs. https://www.nytimes.com/2023/04/12/briefing/abortion-drugs.html?action=click&pgtype=Article&state=default&module=styln-abortion-pills&variant=show&region=MAIN_CONTENT_1&block=storyline_top_links_recirc

McNamee, K., Summers, J., & Kenin, J. (n.d.). Texas judge’s anti-abortion drug ruling is indefensible, says lawyer. https://www.npr.org/2023/04/10/1169122173/texas-judges-anti-abortion-drug-ruling-is-indefensible-says-lawyer

Nanos, E. (n.d.). Doctors can sue FDA to block abortion pill because it’s ‘emotionally taxing’ to treat women who have taken it: Fifth Circuit. https://lawandcrime.com/abortion/doctors-can-sue-fda-to-block-abortion-pill-because-its-emotionally-taxing-to-treat-women-who-have-taken-it-fifth-circuit/